Scleroderma, SystemicPhase 2NCT04647890
Effects of FT011 in Systemic Sclerosis
A Phase 2 study testing FT011 in people with Scleroderma, Systemic and Scleroderma, Diffuse, run by Certa Therapeutics at 10 sites in 5 countries.
Trial summary
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Scleroderma, Systemic, Scleroderma, Diffuse, Sclerosis, Systemic
- What is being tested?
- FT011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 19 Jul 2021to 16 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to any study procedures and who agree to adhere to all protocol requirements.
- Aged 18 to 75 years inclusive at the time of consent.
- Have a classification of systemic sclerosis, as defined by American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria with disease duration ≤10 years from first non-Raynaud phenomenon manifestation.
- Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with skin thickening on the upper arms proximal to the elbows, on the upper legs proximal to the knees, or on the trunk.
- Have skin thickening in a body area suitable for repeat biopsy.
- Have a mRSS at Screening of ≥15 to ≤40.
Show all 9Show fewer
- FVC ≥50% of predicted at Screening.
- If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been on a stable dose for at least 2 months prior to baseline.
- Women of childbearing potential (WOCPB) and males with partners of child-bearing potential must agree to use highly effective contraception (a failure rate of <1%), for the duration of the study and until three months after their last dose of IMP.
Who cannot join
- Pregnant or breast-feeding, or plan to become pregnant during the study.
- Have received any IMP within 30 days or 5 half-lives prior to randomisation (4 months if the previous drug was a new chemical entity), whichever is longer.
- Have known or suspected contraindications to the IMP.
- Have severe or unstable SSc or end-stage organ involvement as evidenced by:
- On an organ transplantation list or has received an organ transplant including autologous stem cell transplant.
- Renal crisis within 1 year prior to Baseline.
Show all 22Show fewer
- Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise.
- Gastrointestinal dysmotility requiring total parenteral nutrition or requiring hospitalisation within the 6 months prior to Baseline.
- Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus erythematosus when definite classification criteria for those diseases are met (Bohan and Peter criteria for polymyositis and dermatomyositis)
- SSc-like illnesses related to exposures or ingestions
- The use of the following drugs within the specified periods:
- Methotrexate in the 2 weeks prior to Day 1
- Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to Screening.
- Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus kinase (JAK) inhibitors, in the 3 months prior to Screening.
- Rituximab in the 6 months prior to Screening.
- Cyclophosphamide oral or IV in the 3 months prior to Screening.
- Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening.
- Have any malignancy not considered cured (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); a subject is considered cured if there has been no evidence of cancer recurrence for the 6 years prior to randomisation.
- Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values above the upper limit of normal (ULN) at Screening or Baseline, or evidence of hepatic disease as determined by any one of the following: history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt.
- Estimated glomerular filtration rate (eGFR) <60mL/min, urinary albumin/creatinine ratio >30mg/g.
- Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L
- Other than SSc, have any other medical condition or significant co-morbidities, clinically relevant social or psychiatric conditions, or any finding during Screening, which in the investigator's opinion may put the subject at risk or interfere with the study objectives.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Poland4 sites
Certa SSc trial site
Bydgoszcz
Certa SSc trial site
Krakow
Certa SSc trial site
Malbork
Certa SSc trial site
Warsaw
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
About this study
Official title: A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
- Being tested
- FT011, Placebo
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT011Drug
Two x 100mg capsules once daily for 12 weeks
FT011Drug
Two x 200mg capsules once daily for 12 weeks
PlaceboDrug
Two placebo capsules once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| FT011 200mg | Experimental | 200mg once daily for 12 weeks Receives: Drug: FT011 |
| FT011 400mg | Experimental | 400mg once daily for 12 weeks Receives: Drug: FT011 |
| Placebo | Placebo comparator | Placebo once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FT011 Levels in Plasma
Measurement of maximum concentration (cmax) of FT011. First dose Cmax and last dose Cmax for each participant were averaged together to calculate a single mean Cmax for each treatment arm
Measured: Mean of cmax post first dose and cmax post last dose
FT011 Levels in Plasma
Measurement of time to cmax (tmax). First dose tmax and last dose tmax for each participant were averaged together to calculate a single mean tmax for each treatment arm
Measured: Mean of time to cmax post first dose and time to cmax post last dose
FT011 Levels in Plasma
Measurement of area under the concentration time curve (AUC). First dose AUC and last dose AUC for each participant were averaged together to calculate a single mean AUC for each active arm
Measured: Mean of AUC hours post first dose and AUC hours post last dose
Secondary outcomes (9)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study
TEAEs per arm during study treatment and follow up periods
Measured: Baseline to Week 16
mRSS Change From Baseline
The mRSS is a validated physical evaluation of patient's skin thickness rated by clinical palpation using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold) for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Total score is 0 to 51 with higher scores indicating worse symptomology
Measured: End of treatment (week 12)
%FVC Change From Baseline
Percent predicted FVC is calculated using equations incorporating age, gender, and race. It is calculated as (FVC Observed / FVC predicted) x 100, where FVC predicted is calculated relative to a reference population
Measured: End of treatment (Week 12)
Physician Global Assessment Change From Baseline
The physician's assessment of the patient's SSc status will be scored on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable disease activity".
Measured: End of treatment (Week 12)
Patient Global Assessment Change From Baseline
The Patient's Global Assessment represents the patient's overall assessment of current SSc status on a 100-mm horizontal VAS, ranging from 0 on the extreme left end of the scale indicating "no disease activity" (symptom free), and 100 on the extreme right end indicating "worst imaginable disease activity".
Measured: End of treatment (Week 12)
Scleroderma HAQ-DI Change From Baseline
The HAQ-DI consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 to 3. The eight scores of the eight sections are summed and divided by 8. The total score indicates the patient's self-assessed level of disability - higher scores indicate worse symptomology. A negative change from baseline indicates improvement. The Scleroderma HAQ (SHAQ) includes an additional five scleroderma-specific visual analogue scales (VAS), addressing overall disease activity, Raynaud's phenomenon, finger ulcers, breathing, and intestinal problems. A composite VAS score is not created nor are the individual VAS scores incorporated into the HAQ DI score.
Measured: End of treatment (Week 12)
Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 12
CRISS components include modified Rodnan skin score (mRSS), forced vital capacity percent predicted (%FVC), Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index (HAQ-DI). The exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in these 5 components. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement
Measured: Week 12
Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) Change From Baseline
The SCTC-DI is a 23-item composite damage index to quantify organ damage in systemic sclerosis (0-55 scale; moderate damage >5, severe damage>12)
Measured: End of treatment (Week 12)
5-D Itch Scale Change From Baseline
The 5-D itch scale is a 23-item validated instrument used to measure five domains of chronic itch: duration, degree, direction, disability, and distribution. Scores range from 5 to 25, with higher scores indicating a higher severity of chronic itch.
Measured: End of treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start19 Jul 2021
- Primary completion12 Oct 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Kelly, PhD, Study director, Certa Therapeutics Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647890
- Sponsor's protocol ID
- CER-FT011-SSc01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2020
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double Blind, Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamic Effects, and Safety, of Oral FT011 in Participants With Diffuse Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04647890
- Acronym / sponsor ID
- CER-FT011-SSc01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Certa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FT011 200mg | Experimental | Drug: FT011200mg once daily for 12 weeks |
| FT011 400mg | Experimental | Drug: FT011400mg once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent prior to any study procedures and who agree to adhere to all protocol requirements.
- Aged 18 to 75 years inclusive at the time of consent.
- Have a classification of systemic sclerosis, as defined by American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria with disease duration ≤10 years from first non-Raynaud phenomenon manifestation.
- Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with skin thickening on the upper arms proximal to the elbows, on the upper legs proximal to the knees, or on the trunk.
- Have skin thickening in a body area suitable for repeat biopsy.
Key exclusion criteria (22 listed)
- Pregnant or breast-feeding, or plan to become pregnant during the study.
- Have received any IMP within 30 days or 5 half-lives prior to randomisation (4 months if the previous drug was a new chemical entity), whichever is longer.
- Have known or suspected contraindications to the IMP.
- Have severe or unstable SSc or end-stage organ involvement as evidenced by:
- Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy. This excludes oxygen used to aid sleep or exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT011Two x 100mg capsules once daily for 12 weeks | Drug | FT011 200mg |
| FT011Two x 200mg capsules once daily for 12 weeks | Drug | FT011 400mg |
| PlaceboTwo placebo capsules once daily for 12 weeks | Drug | Placebo |
Primary outcome
FT011 Levels in Plasma
Time frame: Mean of cmax post first dose and cmax post last dose
Measurement of maximum concentration (cmax) of FT011. First dose Cmax and last dose Cmax for each participant were averaged together to calculate a single mean Cmax for each treatment arm
FT011 Levels in Plasma
Time frame: Mean of time to cmax post first dose and time to cmax post last dose
Measurement of time to cmax (tmax). First dose tmax and last dose tmax for each participant were averaged together to calculate a single mean tmax for each treatment arm
FT011 Levels in Plasma
Time frame: Mean of AUC hours post first dose and AUC hours post last dose
Measurement of area under the concentration time curve (AUC). First dose AUC and last dose AUC for each participant were averaged together to calculate a single mean AUC for each active arm
9 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study
Time frame: Baseline to Week 16
mRSS Change From Baseline
Time frame: End of treatment (week 12)
%FVC Change From Baseline
Time frame: End of treatment (Week 12)
Physician Global Assessment Change From Baseline
Time frame: End of treatment (Week 12)
Patient Global Assessment Change From Baseline
Time frame: End of treatment (Week 12)
Scleroderma HAQ-DI Change From Baseline
Time frame: End of treatment (Week 12)
Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 12
Time frame: Week 12
Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) Change From Baseline
Time frame: End of treatment (Week 12)
5-D Itch Scale Change From Baseline
Time frame: End of treatment (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Scleroderma, Systemic
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)
RecruitingPhase 1
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Kelly, PhD study director
Certa Therapeutics Pty Ltd
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FT011 in people with Scleroderma, Systemic and Scleroderma, Diffuse, run by Certa Therapeutics at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland, Australia, Ukraine, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FT011 Levels in Plasma (time frame: Mean of cmax post first dose and cmax post last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.